1. Field of the Invention
This invention relates to a non-invasive sinus pain relieving assembly and an attendant method for equalizing the pressure between the sinus cavities and the middle ear by isolating the nasal cavities and nasopharynx and subjecting this area to a negative pressure thereby providing immediate relief of normally involved sinus pain, and helping to release trapped middle ear pressure.
2. Description of the Related Art
Currently, there is no commercially available, portable product or device available to the general public without a prescription that mechanically but non-intrusively relieves sinus and middle ear pressure. Present methods of treatment of sinus pain are often chemically related such as numerous vasoconstricting local agents or prescription drugs. Indeed, chemical dependency due to the large numbers of vasoconstrictors in use is very wide spread. In addition, tissue damage from the improper and excessive use of these vasoconstricting chemicals may lead to corrective surgery that is sometimes followed by required cosmetic surgery. Of course, surgery in the sinuses and nasal cavity can easily lead to the spread of infectious agents not only to the sensitive membranes involved but also to the bones forming these cavities.
Specifically, each sinus cavity is lined with a mucous membrane which are substantially continuous with the mucous membrane of the nose and throat. When the nose and nasal cavity fail to produce enough mucous, the sinuses are triggered to overcompensate and make up the difference. Normally, the mucous from the sinuses drain into the nasal cavity through small apertures connecting the two areas. However, if the mucous membrane of the sinuses swells or mucous thickens, due to improper hydration, drainage may be impeded. If this happens, pressure inside the sinus cavities may be trapped. This could cause a differential pressure to exist, squeezing sensitive nerves and possibly causing severe headaches or toothaches. This condition is called barotrauma. Furthermore, if outside barometric pressure increases because of normal weather movement, or with a change in altitude, as in a descending aircraft, auto or during recreation, the condition will worsen. The same condition may effect the middle ears if the bony cartilages of the eustachian tubes becomes obstructed with fluids restricting the equalizing of pressure in the middle ear, additionally referred to as aero otitis media.
When these conditions are encountered the sinuses and/or middle ear are subject to the above from numerous sources. The increasing outside pressure communicating with the nasal cavity, and nasopharynx will try to push into the now trapped low pressure sinus or middle ear through its normal drain apertures, reversing the flow of mucous. Upon this occurring, pressure cannot now be effectively equalized by fluid transfer from a sinus and/or middle ear zone of low pressure, to the nasal cavity and nasopharynx zone of high pressure. As is well accepted, fluid will have a tendency to move from a zone of high pressure to a zone of low pressure.
The slight increase in ambient pressure on the body causes a greater pressure differential between the blood in the swollen sinus tissues and the trapped lower pressure inside the sinus cavity. Additional swelling will therefore occur in the sinus tissue. In the middle ear the tympanic membrane or ear drum is pushed in by the higher outside pressure. This pressure differential will also cause an increase in blood flow to and distortion of the inner ear. Sensitive nerves in this inner ear area will be effected leading to possible pain and/or temporary hearing impairment or both. Of course the actual effects to the human body will vary depending on the size of the pressure differential as set forth above and the duration that such pressure differential is allowed to continue. However, the stress on these delicate membranes opens the door for bacterial infection that can lead to numerous well recognized complications.
Accordingly, there is a need for a mechanically operable, non-intrusive device and attendant method that allows for the rapid release of trapped pressure in the sinus cavities and middle ear thereby serving to equalize the pressure in these zones by taking advantage of the physiological fact that all paranasal sinuses open into the lateral wall of the nasal cavity by means of small apertures to allow for the normal passage or drainage of mucous and accordingly sinus pressure. The middle ear similarly communicates with the nasopharynx by means of the eustachian tube, to drain fluids and maintain a pressure balance with the nasopharynx. A preferred mechanically operable device and method to accomplish the equalization of pressure will isolate the nasal cavity from ambient pressure conditions and establish fluid communication between the rapid acting and easily manipulated pressure regulating structure which will serve to reduce the pressure in the nasal cavity and the nasopharynx thereby forcing the transfer of fluid from the now high pressure zones of the sinus cavities and/or middle ear causing the desired equalization of pressure.
The present invention relates to a portable, non-invasive sinus pain relief assembly and method for the relief of sinus pain through the equalization of pressures between the sinus cavities and the nasal cavity and/or nasopharynx. Common to at least some of the preferred embodiments of the structure of the present invention, to be described in greater detail hereinafter, is the utilization of a mask having a body portion with a hollow interior and a continuous seal structure extending about the outer periphery of the mask. The seal is specifically structured and disposed to define sealing engagement with the face of the user in a surrounding area about the nose and nostrils of the user, and in somewhat outwardly spaced relation thereto, so as to avoid any type of intrusive penetration of the nasal cavity through the nostrils. By establishing the surrounding seal of the present invention, the nasal cavity and associated nasopharynx are isolated from ambient pressure, particularly when the uvula end of the soft palate is forced to rotate rearwardly into engagement with the back portion of the nasopharynx to create a separate pressure chamber of the nasopharynx and nasal cavity. Movement of the uvula in the manner described is accomplished by the patient swallowing while the face mask is in sealing engagement in the aforementioned operative position.
The present invention further comprises a pressure regulating assembly including a vacuum chamber selectively positionable between a collapsed position and an expanded position. The vacuum chamber is connected in preferably direct fluid communication to the inner end of the body portion of the face mask and accordingly in direct fluid communication with the interior of the nasal cavity and nasopharynx, when the aforementioned seal of the mask is disposed in sealing engagement surrounding and effectively isolating the nasal cavity. The pressure regulating assembly is further structured to be selectively manipulated by the hands of the user so as to cause positioning of the vacuum chamber, and parts associated therewith, between the aforementioned collapsed position and expanded position. When in the collapsed position, a minimal amount of air is present within the vacuum chamber. To the contrary, when in the expanded position, the interior volume of the vacuum chamber increases forcing a flow of air from the interior of the mask, and as a result from the interior of the nasal cavity into and/or towards the interior of the vacuum chamber. The result is an initial creation of a negative pressure within the nasal cavity and nasopharynx when the soft palate is forced into engagement with a back portion of the nasopharynx to isolate such cavities. Due to the natural phenomenon of the tendency of fluid to travel from a zone of high pressure towards a zone of low pressure, the initial creation of negative pressure within the nasal cavity will force fluid flow mucous and air through the passages normally interconnecting the sinus cavities with the nasal cavity. Similar fluid flow will result between the cavities of the middle ears and the nasopharynx. The result of course will be an equalization of pressure and the immediate relief of pain caused by swelling and the existence of high pressure in the aforementioned middle ear and/or sinus cavities.
In accomplishing the above results, the present invention contemplates a first structural embodiment, wherein the pressure regulating assembly comprises a flexible material bellows having a hollow interior and is positionable between the aforementioned outwardly expanded position and inwardly collapsed position. The inherent flexibility from which the bellow is formed serves to normally bias the bellows into the outwardly expanded position. An inwardly directed force or pressure exerted on the outer end of the bellows will cause its positioning into the collapsed position. This will vacate the majority of air within the vacuum chamber which is defined by and within the hollow interior of the bellows. The bellows has its inner or proximal end connected in direct fluid communication with the hollow interior of the mask and accordingly in direct fluid communication with the nasal cavity when the aforementioned peripheral seal on the mask is in sealing engagement and in surrounding relation to the nose and nostrils of the patient. As such, a release of the bellows by the user automatically forces the bellows into the outwardly expanded position due to the inherent flexibility of the bellows as set forth above. This in turn will cause a flow of air from the sealed interior of the mask and accordingly from the nasal cavity itself into the vacuum chamber on the interior of the bellows. An initial negative pressure will result in the interior of the nasal cavity causing any fluid (mucous, liquid and/or air) to flow from the now high pressure zone of the sinus cavities and middle ears into the now low pressure zone of the nasal cavity and nasopharynx through connecting passages and apertures. The pressure in the sinus cavities and/or middle ears will therefore be effectively equalized with the pressure in the nasal cavity and nasopharynx resulting in a relief of any pain caused by the existing increased pressure in the sinus cavities and middle ears.
Yet another preferred embodiment of the present invention is defined by a somewhat similar structure as the above noted first embodiment but differs therefrom by incorporating a housing to substantially surround the bellows and allow its movement between the aforementioned expanded position and collapsed position. Further, a positioning member is attached to the outer or distal end of the bellows and is contacted or engaged by the user when a force is desired to be applied to the bellows to move it from its outwardly expanded position to its inwardly collapsed position.
The housing further includes a lock assembly mounted at least partly thereon and partly on the positioning member, such that cooperative components of the subject lock assembly serve to removably retain the bellows in its collapsed position when the components of the lock assembly are engaged with one another. Accordingly, the bellows, through manipulation of the positioning member, may be selectively moved into its collapsed position prior to the face mask being disposed in sealed engagement about the nose and nostrils of the user. Once the bellows is retained in its collapsed position by interaction of the components of the lock assembly, the face mask may be sealed in the desired and intended position. When the seal is accomplished, a release assembly may be activated which serves to separate or disengage the components of the lock assembly causing the bellows to automatically move into its outwardly expanded position without further manipulation by the hands of the user. The aforementioned negative pressure is initially formed in the nasal cavity, as described above with reference to the other preferred embodiment of the present invention.
Yet another preferred embodiment of the structure of the present invention comprises the pressure regulating assembly being defined by a piston movably mounted within a housing, wherein the interior of the housing defines the vacuum chamber. As with the above described preferred embodiments, the piston is movable between an outwardly extending, expanded position and an inwardly disposed, collapsed position. The piston is normally biased to its outwardly expanded position by the existence of a biasing spring located within the vacuum chamber and positioned and structured to accomplish such biasing. A positioning member is movably connected to the piston and is structured to move along a specific path or track formed in the housing and when so moving force the piston from the outwardly expanded position to the inwardly collapsed position. Additional structural features of the positioning member and housing relative to the travel of the piston include an automatic release of the piston once the positioning member reaches an effective bottom of its inwardly directed stroke. When such occurs the piston is automatically released from its collapsed position towards and into its outwardly expanded position to accomplish the aforementioned initial negative pressure within the nasal cavity. A positioning member is then disposed in its outermost, extended position to again assume its engagement with the piston for repeated positioning of the piston into its collapsed position. Travel of the piston between the collapsed and expanded positions should occur when the face mask has established its sealing engagement about the nose and nostrils of the face of the user. A vent assembly is formed on the body and is associated with a valve structure specifically configured to allow the venting of air from the vacuum chamber as the piston travels from the outwardly expanded position to the collapsed position. The vacuum chamber is of course connected in direct fluid communication with the interior of the body of the mask so as to cause the flow of air from the nasal cavity, through the hollow interior of the mask into the vacuum chamber, thereby defining the formation of the initial negative pressure with the nasal cavity.
The factors set forth above which create pain within the sinus cavities can easily be compounded due to a lack of proper hydration in the nasal cavity and other affected areas. Accordingly, the present invention further contemplates an additional preferred structural embodiment and method including an attachment to the other structural components indicated above that allows steam or heated water vapor or saline solution to xe2x80x9cpre-humidifyxe2x80x9d the nasal cavity and nasopharynx under ambient conditions, prior to instigating the use of the structure and as a part of the method of the present invention to affect a lower pressure in the sinus cavities and middle ear. More specifically, a hydrator assembly comprises a housing having a hollow interior in which heated water or saline solution is placed in order to accomplish the hydration process. The upper end of the hydrator housing includes an opening and surrounding fitting which is adaptable for sealing engagement with the interior of the face mask so as to establish direct fluid communication with the interior of the hydrator housing and the interior of the face mask body. A hand manipulated valve structure is mounted on the hydrator housing and serves to selectively segregate or establish communication between the interior of the hydrator housing and the interior of the mask. In operation, the heated water vapor or steam from the heated water in the interior of the hydrator housing rises upwardly through the opening of the top of the housing when the aforementioned valve structure is in its open position. The water vapor passes into the interior of the mask and eventually into the nasal cavity and nasopharynx. The above set forth xe2x80x9cpre-hydrationxe2x80x9d process occurs when the face mask is sealed about the nose and nostrils of the user and the pressure regulating assembly is disposed in its collapsed position.
It is an object of the present invention to provide a non-invasive sinus pain relief assembly which is compact and portable, and an attendant method which is highly effective in addressing a primary source of common sinus pain.
A further object of the present invention is to provide a sinus pain relief assembly and method which does not require any chemical components in order to relieve sinus pain.
An added object of the present invention is to provide a sinus pain relief assembly which is structured to be maintained in an operative, collapsed position upon engagement with a user""s face so as to prevent the introduction of air into the nasal passages upon the operation of the assembly.
Also an object of the present invention is to provide a sinus pain relief assembly and method which is highly effective, yet which operates in a non-invasive manner.